Criteria for inclusion in the GB Register of unacceptable co-formulants

Co-formulants are substances or preparations, which are used or intended to be used in a plant protection product or adjuvant but are neither active substances nor safeners or synergists (Retained Regulation (EC) No 1107/2009, Article 2(3) point (c)).

Article 27 (1) of the same regulation establishes that:

Co-formulants are unacceptable in plant protection products if their residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment
Co-formulants are also unacceptable in plant protection products if their use, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or have an unacceptable effect on plants, plant products or the environment

On this basis unacceptable co-formulants include:

substances with a harmonised classification as carcinogens, category 1A or 1B, as mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B, in accordance with Annex VI to the retained CLP Regulation (EU) No. 1272/2008 as amended for Great Britain
substances identified as persistent, bioaccumulative and toxic (‘PBT’) or very persistent and very bioaccumulative (‘vPvB’) in accordance with points (d) and (e) of Article 57 of Retained REACH Regulation (EC) No. 1907/2006 as amended for Great Britain (UK REACH)
substances of very high concern due to endocrine disrupting properties in accordance with point (f) of Article 57 of Retained REACH Regulation (EC) No. 1907/2006 as amended for Great Britain (UK REACH)
substances identified as endocrine disruptors under Retained Regulation (EU) No 528/2012 as it applies in Great Britain (the GB Biocidal Products Regulation; GB BPR)
substances identified as persistent organic pollutants (‘POP’) under Retained Regulation (EU) 2019/1021
substances restricted for use as co-formulants in plant protection products according to Annex XVII of Retained REACH Regulation (EC) No. 1907/2006 as amended for Great Britain (UK REACH)
polyethoxylated tallowamines (CAS No 61791-26-2)
PHMB (1600; 1.8) [CAS number 27083-27-8 and 32289-58-0] when used as in-can preservatives
PHMB (1415; 4.7), [CAS number 32289-58-0 and 1802181-67-4] when used as in-can preservatives

Unacceptable co-formulants may be present as unintentional impurities in other co-formulants. In this instance the individual concentration of the unacceptable co-formulant in the finished plant protection product or adjuvant should be less than 0.1 % weight by weight (w/w), or lower if a specific concentration limit has been set based on its carcinogenic, mutagenic and reprotoxic properties. Consideration may also be given to limits for unintentional impurities based on technical limitations of relevant analytical methods.